Label: SIGFORM HERBAL MUSCLE- menthol and camphor lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69257-211-21 - Packager: Signature Formulations LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 1, 2015
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Warnings
Discontinue use if irritation or red skin develops, and consult a physician. Application is intended for external cosmetic use only. Consult a health care professional before using this or any product during pregnancy or while breastfeeding. Do not use around the eye area. Do not use if tamper-evident seal is broken or missing. Store in cool dry place.
These statements have not been evaluated by the food and drug administration. This product is not intended to treat, cure or prevent any disease.
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INGREDIENTS AND APPEARANCE
SIGFORM HERBAL MUSCLE
menthol and camphor lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69257-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6 g in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERIN (UNII: PDC6A3C0OX) TRICAPRYLIN (UNII: 6P92858988) STEARIC ACID (UNII: 4ELV7Z65AP) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT OIL (UNII: AV092KU4JH) METHYL SALICYLATE (UNII: LAV5U5022Y) CLOVE OIL (UNII: 578389D6D0) ALOE VERA LEAF (UNII: ZY81Z83H0X) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69257-211-21 90 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/15/2015 Labeler - Signature Formulations LLC (079126258) Registrant - Signature Formulations LLC (079126258) Establishment Name Address ID/FEI Business Operations Signature Formulations LLC 079126258 MANUFACTURE(69257-211)